FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71257–71280 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2003
CONDUCTION CATHETER
K031600 · FRN
Micor, Inc.
General Hospital · 84d
Cleared Aug 13, 2003
IUR FLUID MANAGEMENT SYSTEM
K031616 · HIG
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 82d
Cleared Aug 13, 2003
MODIFICATION TO CERASORB ORTHO
K031651 · MQV
Curasan AG
Orthopedic · 77d
Cleared Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
K031865 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
K032000 · GKZ
Beckman Coulter, Inc.
Hematology · 64d
Cleared Aug 13, 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 41d
Cleared Aug 13, 2003
MODIFICATION TO E-SCAN XQ
K032121 · LNH
Esaote, S.P.A.
Radiology · 35d
Cleared Aug 13, 2003
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K032246 · JSM
Starplex Scientific, Inc.
Microbiology · 22d
Cleared Aug 13, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
K032296 · JIS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d
Cleared Aug 13, 2003
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K032370 · DSI
Ge Medical Systems Information...
Cardiovascular · 12d
Cleared Aug 12, 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 188d
Cleared Aug 12, 2003
XIVE 3.0 DENTAL IMPLANT SYSTEM
K030639 · DZE
Friandent GmbH
Dental · 165d
Cleared Aug 12, 2003
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · FSY
Stryker Endoscopy
General & Plastic Surgery · 130d
Cleared Aug 12, 2003
IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX,...
K031106 · DZE
Imtec Corp.
Dental · 126d
Cleared Aug 12, 2003
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
K031331 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 106d
Cleared Aug 12, 2003
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
K031713 · EWO
Viasys Healthcare, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 12, 2003
CI TKR/UKR
K031770 · HAW
Brainlab AG
Neurology · 64d
Cleared Aug 12, 2003
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
K032146 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 29d
Cleared Aug 12, 2003
CRYOCARE CS SURGICAL SYSTEM
K032333 · GEH
Endocare, Inc.
Radiology · 14d
Cleared Aug 12, 2003
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
K032367 · HSB
Zimmer, Inc.
Orthopedic · 11d
Cleared Aug 11, 2003
BOWIE-DICK MINI PAK, MODEL BD 115
K024293 · JOJ
Steritec Products, Inc.
General Hospital · 230d
Cleared Aug 11, 2003
MALLORY/HEAD TOTAL HIP SYSTEM
K030055 · LPH
Biomet, Inc.
Orthopedic · 217d
Cleared Aug 11, 2003
DEROYAL SURGICAL DRAPES BACKTABLE COVER
K030908 · KKX
Deroyal
General Hospital · 140d
Cleared Aug 11, 2003
LED HEADLIGHT
K031548 · FSR
Welch Allyn, Inc.
Ophthalmic · 87d